Orange Book product · Generic (ANDA)
ERLOTINIB HYDROCHLORIDE
ERLOTINIB HYDROCHLORIDE
At a glance
May 24, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 2024
2 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ERLOTINIB HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209267
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ERLOTINIB HYDROCHLORIDE
- 2004TARCEVABrand (NDA)
NDA 021743 · OSI PHARMS
- 2024ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 203843 · CHARTWELL RX
- 2022ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 216342 · EUGIA PHARMA
- 2021ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 214719 · ALEMBIC
- 2021ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 214366 · MSN
- 2020ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 091059 · TEVA PHARMS USA INC
- 2020ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 211083 · ACCORD HLTHCARE
- 2020ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 213065 · ZYDUS PHARMS
- 2019ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 208396 · APOTEX
- 2019ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 208488 · NATCO PHARMA LTD
- 2019ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 211960 · SHILPA
- 2019ERLOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 210300 · SUN PHARM
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
